Clinical trial · Interventional
A Single-arm Exploratory Study of Neoadjuvant Therapy
Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cis-platemum | Drug | — | UNRESOLVED |
| or carboplatin | Drug | — | UNRESOLVED |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant ICI combined with chemotherory
- description
- intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
- interventionNames
- Drug: Tislelizumab
- Drug: pemetrexed
- Drug: cis-platemum
- Drug: or carboplatin
Primary outcomes (1)
- measure
- Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）
- timeFrame
- 15-18 weeks after enrollment
- description
- MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures; 2. Age 18-75 (boundary value included), no gender limitation; 3. Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition); 4. EGFR gene mutation positive (can be tested by tissue or blood samples); 5. PD-L1 ≥ 1% 6. ECOG PS score 0-1 (including boundary value); 7. Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed; 8. Meet the conditions for receiving platinum containing two-drug chemotherapy; 9. The expected survival time is ≥3 months, and feasible surgery is planned; Exclusion Criteria: 1. Any previous treatment for current lung cancer, including systemic therapy or radiotherapy; 2. there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV). 3. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom
References
Publications (5)
- BACKGROUNDChansky K, Detterbeck FC, Nicholson AG, Rusch VW, Vallieres E, Groome P, Kennedy C, Krasnik M, Peake M, Shemanski L, Bolejack V, Crowley JJ, Asamura H, Rami-Porta R; IASLC Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions. The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1109-1121. doi: 10.1016/j.jtho.2017.04.011. Epub 2017 Apr 28. PMID 28461257
- BACKGROUNDWozniak AJ, Gadgeel SM. Adjuvant therapy for resected non-small cell lung cancer. Ther Adv Med Oncol. 2009 Sep;1(2):109-18. doi: 10.1177/1758834009338634. PMID 21789116
- BACKGROUNDRosell R, Lopez-Cabrerizo MP, Astudillo J. Preoperative chemotherapy for stage IIIA non-small cell lung cancer. Curr Opin Oncol. 1997 Mar;9(2):149-55. doi: 10.1097/00001622-199703000-00008. PMID 9161793
- BACKGROUNDZhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13. PMID 31194613
- BACKGROUNDNSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25. PMID 24576776